Light Sources LS-1800XG (Med Light X180), LS-3000X, LS-2500H (Med Light H250) provide illumination for fiberoptic endoscopy to gastroenterological and urological cavities, hollow organs and canals.

Device Description

The Endoscopic Light Source LS-300X uses a 300W xenon lamp to provides illumination during endoscopic diagnostic and surgical procedures through a fiber optic cable, which is connected to the device. Brightness can be adjusted manually. The color temperature is approximately 5600°K and the lamp life is approximately 500 hours.

The Endoscopic Light Source LS-1800X (Med Light X 180) uses a 180W xenon lamp to provides illumination during endoscopic diagnostic and surgical procedures through a fiber optic cable, which is connected to the device. Brightness can be adjusted manually. The color temperature is approximately 6000°K and the lamp life is approximately 500 hours.

The Endoscopic Light Source LS-2500H (Med Light H 250) uses two 250W halogen lamps to provides illumination during endoscopic diagnostic and surgical procedures through a fiber optic cable, which is connected to the device. Brightness can be adjusted manually. The color temperature is approximately 3400°K and the lamp life is approximately 50 hours.

AI/ML Overview

The provided text describes a 510(k) premarket notification for an Endoscopic Light Source. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set ground truth cannot be fully extracted from the provided text because it primarily addresses regulatory compliance through substantial equivalence.

Here's why and what information can be gathered:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in terms of performance metrics like sensitivity, specificity, or image quality scores. Instead, the "acceptance criteria" are implied by the requirement to be "substantially equivalent" to predicate devices. This means the device must perform similarly to widely accepted and commercialized devices.
Reported Device Performance: The primary "performance data" mentioned is compliance with several international and European standards, indicating safety and general functionality. No specific individual performance metrics are provided that would typically populate such a table for an AI/diagnostic device.

Criteria (Implied)	Performance (Reported)
Substantial Equivalence to Predicate Devices (K021717, K023468, K20889)	"The new devices have no diminished safety or effectiveness." "The differences... are minor and raise no new questions of safety and effectiveness."
Compliance with IEC 60601-1 (General medical electrical equipment)	Will comply
Compliance with IEC 60601-1-2 (Electromagnetic compatibility)	Will comply
Compliance with IEC 60601-2-18 (Endoscopic equipment)	Will comply
Conformance to Medical Device Directive 93/42/EEC	Will conform
Illumination for fiberoptic endoscopy to gastroenterological and urological cavities, hollow organs and canals	Intent of the device
Lamp Characteristics (W, color temp, life)	Listed for each model (e.g., LS-3000X: 300W Xenon, 5600°K, 500 hrs)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable/Not provided. This is not a clinical study involving a "test set" of patient data. The evaluation is largely based on technical specifications and comparison to existing devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided. Ground truth for a diagnostic test is not relevant here as this is a medical device for illumination, not for diagnosis based on data interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable/Not provided. This is an endoscopic light source, not a diagnostic AI tool, so MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable/Not provided. This is a hardware device, not an algorithm. Its "standalone" performance is its ability to produce light according to its specifications.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable/Not provided in the context of a diagnostic test. The "truth" for this device lies in its technical specifications and compliance with safety and performance standards.

8. The sample size for the training set

Not applicable/Not provided. This device is not an AI model that requires a training set.

9. How the ground truth for the training set was established

Not applicable/Not provided. As above, no training set is relevant.

Summary in relation to the provided document:

The provided document is a 510(k) summary, which aims to demonstrate that a new medical device is "substantially equivalent" to existing, legally marketed predicate devices. This regulatory pathway relies on comparing the new device's technological characteristics, intended use, and safety/effectiveness profile to the predicates, rather than conducting new clinical trials to establish novel performance metrics or compare it against a gold standard in a diagnostic context.

The "study" that proves the device meets the (implied) acceptance criteria of substantial equivalence is primarily a technical assessment and comparison to established predicate devices and compliance with relevant international and European standards for medical electrical equipment. No clinical studies involving patient data, expert readers, or AI algorithms were conducted or reported in this summary.

Summary

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K032545-

510(k) CUJ Summery/ Statement 8

510(k) CUJ Summery/ Statement for LS-3000X, LS-1800XG (Med Light X 180) and LS-2500H (Med Light H 250)

I	Submitter
---	-----------

MGB Endoskopische Geräte GmbH Berlin Schwarzschildstraße 6 12489 Berlin Germany

Device Names II

1.	Classification Name:	Accessory to an Endoscope
2.	Common or Usual Name:	Endoscopic Light Source (Xenon Light Source)
3.	Proprietary Name:	Endoscopic Light Source LS-3000X, LS-1800 XGand LS-2500H for MGB brandMed Light X 180 and Med light H 250 for LAWTONbrand

Classification: III

Class II. This device is described in21 C.F.R.§876.1500: The product code for the device is GCT.

IV Predicate Device:

name/ manufacturer:	World of Medicine Lemke GmbH
labeling:	For LS-1800XG (Med Light X 180): Endoscopic Light source XL180/L3For LS-3000X :Endoscopic Light source XL300/L5For LS-2500H (Med Light H 250): Endoscopic Light source XL202/L3

V Intended Use:

The light Sources LS-3000X, LS-1800XG (Med Light X180), LS-2500H (Med Light H250) provide illumination for fiberoptic endoscopy to gastroenterological and urological cavities, hollow organs and canals.

VI Device Describtion

The Endoscopic Light Source LS-1800X (Med Light X 180) uses a 180W xenon lamp to provides illumination during endoscopic diagnostic and surgical procedures through a fiber

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optic cable, which is connected to the device. Brightness can be adjusted manually. The color temperature is approximately 6000°K and the lamp life is approximately 500 hours.

VII Substantial Equivalence

The submitted devices pose the same type of questions about safety and effectiveness as the predicate device. The new devices have no diminished safety or effectiveness. The LS-3000X is similar in design and technological characteristics to the Endoscopic Light Source XL300/L5 (K021717), the LS-1800XG (Med Light X 180) is similar in design and technological characteristics to the Endoscopic Light Source XL180/L3 (K023468) and the LS-2500H (Med Light H 250) is similar in design and technological characteristics to the Endoscopic Light Source XL202/L3 (K20889), manufactured by World of Medicine Lemke GmbH.

Both the LS-3000X, LS-1800XG (Med Light X 180), LS-2500H (Med Light H 250) and the predicate device are intended to provide illumination of body cavities, hollow organs and canals during endoscopic diagnostic and surgical procedures. In addition, both devices are designed to be used the same lamps.

The differences between the LS-3000X, LS-1800X (Med Light X 180), LS-2500H (Med Light H 250) and the predicate devices are minor and raise no new questions of safety and effectiveness. Accordingly, MGB Endoskopische Geraete GmbH Berlin believes that the Endoscopic Light sources LS-3000X, LS-1800X (Med Light X 180), LS-2500H (Med Light H 250) are substantially equivalent to the predicate devices currently on the market.

VIII Performance Data

The Endoscopic Light sources LS-3000X, LS-1800X (Med Light X 180), LS-2500H (Med Light H 250) will comply with the International Standard IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18 and will conform to the Medical Device Directive 93/42/EEC.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 2 2003

MBG Endoskopische Geräte GmbH % Mr. Stefan Preiss Responsible Third Party Official TÜV America, Inc. TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891 Re: K032545

Trade/Device Name: LS-3000S; LS-1800XG/Med Light X 180; LS-2500H/Med Light H 250 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FET Dated: August 1, 2003 Received: August 18, 2003

Dear Mr. Preiss:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive. Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K032545

Statement of Indications for use 3

Applicant:

MGB Endoskopische Geräte GmbH Berlin

510(k) Number:

K032545

Device Name:

Endoscopic Light Source (Xenon Light Source)

LS-1800XG (for MGB brand), Med Light X 180 (for Lawton brand) LS-3000X (for MGB brand) LS-2500H (for MGB brand), Med Light H 250 (for Lawton brand)

Indications for Use:

Light Sources LS-1800XG (Med Light X180), LS-3000X, LS-2500H (Med Light H250) provide illumination for fiberoptic endoscopy to gastroenterological and urological cavities, hollow organs and canals.

Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 C.F.R. $ 801.109)

Prescription Use ✓

Nancy L. Hodgson

Division Sian Division of Reprodu and Radiological Devic 510(k) Number

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.